Manages and executes the activities of OUS Regulatory Affairs, coordinating closely with Quality, R&D, OUS Clinical Research and others on the development, submission, and prosecution of OUS Regulatory filings. Over time, this role will potentially evolve to include participation in US regulatory filings as well but initially will be focused on OUS markets.
If necessary, fill the role of the Person Responsible for Regulatory Compliance under the EU Medical Device Regulation 2017/745.
Specific Functions and Responsibilities:
- Develops and executes regulatory filings in non-US markets which may include EU, Australia, Asia, Canada, South, and Central American countries.
- Work with the commercial teams to prioritize new market filings and communicate pathways, timelines, and budgets. Maintain consistent communication regarding status and changes.
- Interface with OUS distributors, regulatory agencies, and consultants to understand and optimize regulatory processes by market.
- Assists with US regulatory processes as needed.
Responsibilities associated with PRRC
- Assists with and/or manages regulatory compliance inspections and audits, e.g., FDA, notified body.
- The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
- The post-market surveillance obligations are in compliance with the EU Medical Device Regulation 2017/745.
The above description outlines the most common job duties; however, it does not exclude other potential work assignments.
Education or Formal Training Required:
- Technical college degree required, in combination with applicable training and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)
- Experience in managing regulatory filings in non-US markets
- Good planning and prioritization skills
- Strong interpersonal and team skills
- Strong decision-making skills
- Good writing skills
- Good computer and word processing skills
- Adaptable to various job duties as necessary in a small company
Work Conditions / Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.
- This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
- This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
- This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
- Potential exposure to dust, noise, and odor.
- Potential exposure to various chemicals.
Travel Required: Occasional. Less than 10%.
Benefits/Compensation (including but not limited to)
Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.
Salary Range: 130-160k/year
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.